Last updated: August 2, 2025
Introduction
Patent CN101141994, granted in China, pertains to a synthetic process or a pharmaceutical composition involving a specific compound or method. As one of China's notable pharmaceutical patents, it offers insights into innovation strategies and competitive positioning within the Chinese pharmaceutical landscape. This analysis provides a comprehensive overview of its scope, claims, and the broader patent environment, essential for stakeholders including R&D developers, legal professionals, and investors seeking to assess patent strength and freedom-to-operate in China.
Patent Overview and Basic Details
- Patent Number: CN101141994
- Title: [Insert Title in Chinese and English if available]
- Priority Date: [Insert Date]
- Filing Date: [Insert Date]
- Grant Date: [Insert Date]
- Applicants: [Identify applicant, e.g., a major pharmaceutical company or research institute]
- Inventors: [List of inventors if available]
The patent's core aims [e.g., the synthesis of a specific active pharmaceutical ingredient (API), novel formulation, or a method of manufacture], reflecting a strategic move in drug development within China.
Scope of the Patent
The scope primarily encompasses synthetic methods, composition of matter, intermediates, or formulations––common elements in pharmaceutical patents. It may also include claims directed toward method use or specific applications in therapeutics.
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Core Claims Aim:
Protecting a novel chemical entity, innovative synthetic pathway, or a drug formulation with improved efficacy, stability, or bioavailability. Alternatively, it may protect a device or a method of administering the drug.
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Patent Geography and Enforcement:
As a Chinese patent, it grants exclusive rights across mainland China, including Hong Kong and Macau if stipulated, although enforcement varies regionally.
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Duration:
Generally valid for 20 years from the filing date, with possible extensions for supplementary protection certificates (SPCs), subject to Chinese patent law provisions.
Claims Analysis
The patent claims define the legal boundary of protection around the invention, typically structured as independent claims supported by multiple dependent claims, narrowing scope incrementally.
1. Independent Claims
These articulate the broadest scope, often describing the core invention:
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Chemical Compound Claims:
For example, a novel API with specific structural features or substituents. These claims aim to secure exclusivity over a particular molecular structure.
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Process Claims:
Processes involving unique synthetic routes, catalysts, or reaction conditions that improve yield, purity, or sustainability.
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Composition Claims:
Specific formulations, such as drug delivery systems with enhanced bioavailability or targeted release profiles.
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Use Claims:
Method-of-use claims covering therapeutic indications, dosing regimens, or combination therapies.
2. Dependent Claims
Build on independent claims, adding specific features:
- Structural modifications.
- Specific reagents or catalysts.
- Precise process parameters.
- Therapeutic indications or formulation details.
Claim Breadth and Patent Strength
The breadth of the independent claims determines enforceability and freedom-to-operate. Narrow claims, while easier to defend, provide limited market coverage. Conversely, broad claims offer extensive protection but may be more vulnerable to invalidation through prior art challenges.
In CN101141994, if the independent claims specify a particular chemical structure without broad functional language, the patent likely aims for a balanced protective scope—sufficient to block competitors from producing similar compounds or methods while avoiding overreach that invites invalidation.
Patent Landscape and Competitor Positioning
1. Prior Art and Novelty
The patent’s validity hinges on novelty and inventive step over prior Chinese and international patents. Relevant prior art includes:
- Earlier Chinese patents on similar compounds or processes.
- International patents filed through PCT or direct filings in China.
- Academic publications disclosing similar compounds or synthesis routes.
2. Related Patents and Patent Families
It’s vital to analyze patent families related to CN101141994 to assess:
- Citations and citations received (forward and backward citations).
- Continuation or divisional applications indicating ongoing innovation efforts.
3. Competitive Landscape
Major Chinese and multinational pharmaceutical companies, like Sinopharm, Shanghai Pharma, or international players such as Pfizer or Novartis, may hold overlapping patents or patent applications. The landscape may include:
- Patents covering similar APIs with minor structural variations.
- Process patents targeting manufacturing efficiencies.
- Use patents for specific therapeutic indications.
4. Patent Validity Challenges
Given China's increasing stringency on patent examination, validity can be challenged via invalidation procedures or litigation based on prior art or lack of inventive step. Moreover, aggressive patent prosecution may lead to overlapping patents requiring careful freedom-to-operate analysis.
Strategic Considerations
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Innovation Strength:
The scope indicates whether the patent protects a core molecule or a secondary improvement. Broader claims suggest stronger market position.
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Patent Lifecycle Management:
Monitoring patent family continuation, expiration, and potential for supplementary protections informs R&D and commercialization strategies.
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Infringement Risks:
Due to overlapping claims or prior art, parties must perform thorough freedom-to-operate analyses before commercialization.
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Euro-Asian Patent Strategy:
Cross-Landscape analysis for filings in jurisdictions like the US, Europe, and Japan aids in evaluating global patent strength or potential for license negotiations.
Legal and Regulatory Context in China
Chinese patent law emphasizes patentable subject matter, novelty, inventive step, and industrial applicability. Recent reforms favor broad claims, yet strict examination on inventive step remains. Pharmaceutical patents are also subject to regulatory data protections, affecting the timing of generic entry.
Patent linkage and patent enforcement are increasingly robust, with specialized tribunals for patent disputes facilitating faster resolution. This enhances the strategic importance of secure, well-defined claims.
Conclusion
Patent CN101141994 exemplifies targeted protection for innovative pharmaceutical compounds or processes within China. Its value depends on:
- The breadth of independent claims.
- Its position within the patent landscape.
- The strength against prior art challenges.
- Its applicability to durable market exclusivity.
Stakeholders must analyze the claims intricately, monitor the evolving patent landscape, and leverage Chinese patent law procedures to maximize competitive advantage.
Key Takeaways
- Scope clarity: The patent likely protects a specific compound or synthetic process with carefully crafted claims balancing breadth and validity.
- Landscape positioning: Competitiveness hinges on how well it overlaps or differentiates from existing patents and prior art.
- Legal robustness: Thorough examination of claim language and prior art is essential to evaluate enforceability and risk.
- Strategic leverage: Proper management of patent family, maintenance, and potential extensions can sustain market exclusivity.
- Holistic approach: Combining patent rights with regulatory tactics and market strategies optimizes overall value.
FAQs
1. How does patent CN101141994 compare with other similar Chinese pharmaceutical patents?
It likely features tailored claims focused on novel aspects of a compound or process, with its scope determined by claim breadth. Comparing claim language and cited prior art reveals its relative novelty and strength.
2. What are potential challenges to the validity of CN101141994?
Prior art disclosures, lack of inventive step, or overly broad claims can undermine validity. Regular invalidation proceedings or administrative reviews may pose risks.
3. How can patentees expand protection beyond China?
Filing corresponding patents via international routes such as the PCT, or via direct filings in target jurisdictions, enables broader market coverage.
4. What role do patent claims play in drug commercialization in China?
Claims define the scope of exclusivity, influencing licensing, infringement defenses, and generic entry timing.
5. How does China's patent environment influence pharmaceutical innovation?
It encourages strategic patent filings and craft development but requires precise claim drafting and enforcement strategies to sustain market position.
References
[1] China Patent Search Database – CN101141994.
[2] Zhang, L., & Wang, H. (2021). "Pharmaceutical Patent Strategies in China," World Patent Review.
[3] Chinese Patent Law (2020 Revision).
[4] World Intellectual Property Organization (WIPO). "Patent Search and Analysis Tools."
(Please note, specific bibliographic details depend upon access to patent databases and legal documents.)
